Cleared Traditional

K900486 - APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER
(FDA 510(k) Clearance)

K900486 · Davis & Geck, Inc. · General & Plastic Surgery

Apr 1990

Decision

78d

Days

Class 1

Risk

K900486 is an FDA 510(k) clearance for the APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER. This device is classified as a Staple, Removable (skin) (Class I — General Controls, product code GDT).

Submitted by Davis & Geck, Inc. (Danbury, US). The FDA issued a Cleared decision on April 20, 1990, 78 days after receiving the submission on February 1, 1990.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4760.

Submission Details

510(k) Number	K900486 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 1990
Decision Date	April 20, 1990
Days to Decision	78 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—